Osteoporosis

January 17, 2019FDA News, OsteoporosisComments Off on FDA Advisory Committee Recommends Approval of Amgen and UCB’s Evenity for Treatment of Postmenopausal Women with Osteoporosis

THOUSAND OAKS, Calif. and BRUSSELS, Jan. 16, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced strong support from the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) for the approval of EVENITY™* (romosozumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture after reviewing safety and …

July 13, 2018FDA News, OsteoporosisComments Off on Amgen and UCB Resubmit BLA for Evenity to the FDA for the Treatment of Osteoporosis

THOUSAND OAKS, Calif. and BRUSSELS, July 12, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY™* (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY increases bone …

July 17, 2017FDA News, OsteoporosisComments Off on FDA Rejects Amgen’s Romosozumab for Treatment of Postmenopausal Women with Osteoporosis

THOUSAND OAKS, Calif. and BRUSSELS, July 16, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologics License Application (BLA) for EVENITY™* (romosozumab) as a treatment for postmenopausal women with osteoporosis. The original submission included data from the pivotal …

May 1, 2017FDA News, OsteoporosisComments Off on FDA Approves Radius’ Tymlos for Treatment of Postmenopausal Women with Osteoporosis

WALTHAM, Mass., April 28, 2017 (GLOBE NEWSWIRE) — Radius Health, Inc. (Nasdaq:RDUS), a science-driven fully integrated biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, today announced that the US Food and Drug Administration (FDA) has approved TYMLOS (abaloparatide) injection for …

April 3, 2017OsteoporosisComments Off on Amgen and UCB Report New Data Examining the Option of A Second Course Treatment with Evenity

THOUSAND OAKS, Calif. and BRUSSELS, April 1, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced results from the fourth year of a Phase 2 study showing the efficacy and safety of a second course of treatment with EVENITY™* (romosozumab), an investigational agent for postmenopausal women with osteoporosis. …

September 2, 2016Business News, OsteoporosisComments Off on Merck Discontinues Development of its Osteoporosis Candidate due to Stroke Risk

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that it is discontinuing the development of odanacatib, Merck’s investigational cathepsin K inhibitor for osteoporosis, and will not seek regulatory approval for its use. Merck previously reported a numeric imbalance in adjudicated stroke events in …